Methods, systems and devices for a clinical data reporting and surgical navigation

ABSTRACT

Three components are proposed, each having at its core a system for producing measurements of the relative motion of anatomical structures of mammals (the “measurement system”). The measurement system in this case would be comprised of an apparatus for imaging the joint of through a prescribed motion, and a process and mechanism for deriving quantitative measurement output data from the resulting images. The components of the present invention include: (1) a software device for reporting measurement output of the measurement system and for allowing users to interact with the measurement output data; (2) an apparatus and method for utilizing measurement output of the measurement system for therapeutic and surgical applications such as surgical navigation and patient positioning during a therapeutic procedure; and (3) an apparatus providing input image data for the measurement system that assists with the imaging of joints connecting anatomical regions that are in motion during operation.

CROSS-REFERENCE

This application claims the benefit of U.S. Provisional Application Nos.61/422,283, filed Dec. 13, 2010, entitled Methods, Systems and Devicesfor a Clinical Data Reporting Software System, 61/444,265 filed Feb. 18,2011, entitled Methods, Systems and Devices for A Clinical DataReporting And Surgical Navigation, 61/453,236 filed Mar. 16, 2011entitled Methods, Systems and Devices for a Clinical Data ReportingSoftware System, 61/454,601 filed Mar. 21, 2011, entitled Methods,Systems and Devices for a Clinical Data Reporting Software System andProduct Design Tools, and 61/499,272 filed Jun. 21, 2011, entitledMethods, Systems and Devices for a Clinical Data Reporting and SurgicalNavigation which applications are incorporated herein by reference.

BACKGROUND OF THE INVENTION

One of the most prevalent joint problems is back pain, particularly inthe “small of the back” or lumbosacral (L4-S1) region. In many cases,the pain severely limits a person's functional ability and quality oflife. Such pain can result from a variety of spinal pathologies. Throughdisease or injury, the vertebral bodies, intervertebral discs, laminae,spinous process, articular processes, or facets of one or more spinalvertebrae can become damaged, such that the vertebrae no longerarticulate or properly align with each other. This can result in anundesired anatomy, loss of mobility, and pain or discomfort. DukeUniversity Medical Center researchers found that patients suffering fromback pain in the United States consume more than $90 billion annually inhealth care expenses, with approximately $26 billion being directlyattributable to treatment. Additionally, there is a substantial impacton the productivity of workers as a result of lost work days. Similartrends have also been observed in the United Kingdom and othercountries.

As part of the diagnostic process of determining the cause of paincoming from a joint such as the lumbar spine, health care providers relyon an understanding of joint anatomy and mechanics when evaluating asubject's suspected joint problem and/or biomechanical performanceissue. Currently available orthopedic diagnostic methods are capable ofdetecting a limited number of specific and treatable defects. Thesetechniques include X-Rays, MRI, discography, and physical exams of thepatient. In addition, spinal kinematic studies such as flexion/extensionX-rays are used to specifically detect whether or not a joint hasdysfunctional motion. These methods have become widely available andbroadly adopted into the practice of treating joint problems andaddressing joint performance issues.

U.S. Patent No. US 2004-0172145 A1 discloses a tilting table capable ofsome movement to keep an iso-center at a fixed position. U.S. PatentPublication No.: US 2006-0185091 A1 describes a multi-articulatedtilting table which positions and supports a subject during examinationand treatment. U.S. Pat. Publication No. US 2005-0259794 A1 to Breendiscloses a device for controlling joint motion and minimizing theeffects of muscle involvement in the joint motion being studied. Seealso U.S. Pat. No. 7,502,641. This device minimizes variability amongjoint motion measurements across wide populations of subjects. As aresult, comparative analyses of such measurements can be performed todetermine statistical differences between the motion of “normal” and“unhealthy” subjects which in turn can provide a basis for determiningthe statistical confidence with which any given subject could beconsidered “normal” or “unhealthy” based solely on joint motionmeasurements. US 2009/0099481 A1 to Deitz for Devices, Systems andMethods for Measuring and Evaluating the Motion and Function of Jointsand Associated Muscles discloses an apparatus configured to cause andcontrol joint motion of a patient.

New approaches that involve the use of patient positioning devicesduring imaging discussed above, coupled with the use of imagingmodalities that afford for moving-video type images (such asfluoroscopy) and automated computer image processing, have created newclinical diagnostic capabilities. These capabilities include the abilityto produce low variability, quantitative measurements of the relativemotion between anatomical structures in mammals, and in particular theability to measure inter-vertebral kinematics in live human subjects.These new capabilities have been validated in clinical studies tosignificantly outperform older methods, such as flexion/extensionX-rays, in determining whether or not a human spine joint hasdysfunctional motion. With the development of these new systems forassessing inter-vertebral kinematics, there arises the need forcomponents to enable a number of clinical applications of thisnewly-available diagnostic data.

One need is for new ways of viewing this new type of kinematic data.Another need is for the ability to leverage this data to improve uponthe tools that users have in providing therapy to patients. Yet anotherneed is to be able to generate measurement system results for anatomythat is typically hard or impossible to image, such as anatomy that doesnot stay fixed in space during operation, such as a knee (as opposed toa lumbar spine, which can be easily imaged with a fixed imaging device).

SUMMARY OF THE INVENTION

Three components to the system are proposed, each component is adaptedand configured to work with a measurement system or device for producingor obtaining measurements of a relative motion of anatomical structuresof mammals. The measurement system in this case would be comprised of,for example, an apparatus for imaging a target joint through aprescribed range of motion to obtain one or more images, and a processor device for deriving quantitative measurement output data from theimages. The components of the present disclosure include: (1) a softwaredevice having a user interface which delivers data from the measurementsystem; (2) an apparatus and method for utilizing measurement output ofthe measurement system for therapeutic and surgical applications such assurgical navigation and patient positioning during a therapeuticprocedure; and (3) an apparatus providing input image data for themeasurement system that assists with imaging during joint operation toafford for the imaging of joints connecting anatomical regions that arein motion during operation. The user is typically a healthcare provideror clinician.

The first of these three components, the clinical data reportingsoftware interface, is an algorithm encoded in computer-readable mediawhich delivers to a user interface at least one measurement output fromthe measurement system communicate through the process of initializationby a user, interpretation of results from the measurement system, andcomparison with aggregated data contained in the computer readablemedia. The software interface is configured to operate in acommunications network, and with one or more input and output devices.

The clinical data reporting software interface allows the user toinitialize the system once prior to or during a first use of thesoftware interface to define, for example, a list of one or moreprocedures of interest, one or more associated risks, and one or morerisk mitigation factors associated with each procedure. Theinitialization information can be updated as often as desired, and/orcan be dynamically updated by communication with an service provided.These risk and risk mitigation factors relate to the appropriateness ofa particular procedures in view of a specific patient's presentations.The combination of risk and risk mitigation factors are definable asspecific alerts in the reporting system that can be presented to theuser for consideration of changes to planned procedures for each patientbased on that patient's specific measurement system testing results.

The clinical data reporting software interface integrates userpreferences for procedures of interest along with associated riskfactors and risk mitigation factors to facilitate interpretation ofpatient specific results for specific kinematic dysfunctions, at eachspine level. Threshold limits for quantitatively detecting kinematicdysfunctions can be set and changed interactively by the user.

The clinical data reporting software interface provides a process andmechanism for collecting additional data on each subject to include:demographic, height/weight/other physical measurements, subject history,symptoms, co-morbidities, neurologic exam results, prior proceduresperformed and related outcome, and others; as well as a process anddevice for transmitting this additional data to an aggregated database.

The clinical data reporting software interface provides a process anddevice for collecting aggregated data from all subjects tested, creatinga database that can be used for consideration and comparison of outcomesfor subjects matched based on: 1) kinematic presentation, 2) additionaldata collected, and 3) procedure being considered. User can viewpotential clinical outcomes of procedure being considered by queryingaggregated database.

The clinical data reporting software interface interprets kinematicresults of subjects that were tested in a standing or lying downposition, which allows for isolating the muscle or load contribution,and additionally allowing for the use of this data within a computermodel of spine biomechanics that can further isolate the potentialmuscular and soft tissue causes of any functional problems.

The surgical navigation and patient positioning system is an apparatusand method for utilizing measurement output of the measurement systemduring therapeutic procedures. It comprises a communications network,communication medium, input and output devices, computing applicationand software application that communicate and compute data through theprocess of acquisition of data from the measurement system, processingof data to determine appropriate target geometric and spatialparameters, communicating this data to a surgical navigation systemand/or a patient positioning device (such as an intra-operative patientpositioning device).

The surgical navigation and patient positioning system provides amechanism to incorporate kinematic data into systems used by usersduring therapeutic procedures, specifically surgical navigation andsurgical patient positioning systems. In the case of surgicalnavigation, an apparatus and method are provided for determining theoptimal geometry for a surgical construct; such as determining theoptimal spatial relationships between and among an inter-body device,posterior rods and screws, and two vertebral endplates for spinal fusionsurgical construct. Once determined, the data describing this optimalgeometry is then communicated to a surgical navigation system andincorporated into the system's targeting module, so that the surgicalnavigation system can be used to assist the surgeon in achieving optimalgeometry for the surgical construct. In the case of patient positioning(such as intra-operative patient positioning), an apparatus and methodare provided for determining and achieving the optimal positioning ofthe patient on the procedure table. Once determined, the data describingthis optimal positioning of the patient is then communicated to asurgical patient positioning system and incorporated into the positioncontrol system so that the optimal patient position can be achievedduring surgery. The control system can additionally be in communicationwith additional patient data collection systems to provide real timefeedback as to the effect of patient positioning changes on theposition, orientation, and motion of the anatomy of interest, for thepurpose of allowing the control system to achieve the target anatomicalgeometry and orientation by adjustments made to the surgical patientpositioning system.

The imaging system is adaptable to be moveable within a vertical planeand is an apparatus providing input image data for the measurementsystem that assists with imaging during joint operation. It consists ofa medical imaging system mounted to a free floating, ballasted verticalplane, so that the medical imaging system can be moved to keep jointanatomy within a moving field of view, such as keeping a knee in a fieldof view as a live human testing subject is walking. It incorporatesmotion recording sensors position-able with respect to an imageintensifier system motion, with attachment mechanisms to engage themedical imaging system or the recording sensors to piece of humananatomy. It may additionally incorporate actuators capable of providingthe motive force to affect a repositioning of the medical imagingsystem.

Having an imaging system moveable within a vertical plane is ideal foruse with joints that connect two anatomical regions that both move, suchas the human knee that connects the tibia/fibula to the femur, both ofwhich are in motion during operation of the knee. This is in contrast tojoints where one of the two anatomical regions connected by the jointstays relatively fixed, such as the torso for shoulder rotation, or thepelvis for lumbar spine rotation, and therefore can be imaged with afixed imaging system such that the joint stays in within the field ofimaging during operation. When both of the anatomical regions connectedby a joint are in motion, it can be impossible to keep that joint withina field of view unless the imaging system is moving as well, which is anoperational objective of the imaging system moveable within a verticalplane.

For all three of the components included in the present disclosure, theinputs, information and reports can be transmitted through either adirect wire-based electronic connection between the two or morecomponents, or through a wireless connection, and can be of the typethat is derived from computer programming or from operator, user orsubject input, or from a combination of computer programmed informationplus operator, user and/or subject input. Those skilled in the art willappreciate that the system described herein can be applied orincorporated into any communications network, communication medium,input and output devices and computing application available now andwhat will be available in the future.

An aspect of the disclosure is directed to a method forcomputer-assisted analysis of kinematic data. A method comprising, forexample, encoding a kinematic evaluation algorithm as one or moredecision trees, each decision tree further comprising, one or moredecision points comprising one or more questions; and one or moretermination points, providing one or more images for a patient from animaging system; initiating an evaluation by identifying one or moreproposed procedures for the patient; evaluating the proposed procedureapplied to the one or more images from the imaging system according tothe algorithm; comparing the evaluation of the proposed procedure to auser profile; and providing a summary of one or more alerts for the oneor more proposed procedures based on the user profile and the one ormore patient images. Additionally, the method can be performed on acommunication network. In some aspects, the method further comprises thesteps of: creating a user profile prior to the step of providing one ormore images from an imaging system wherein the step of creating furthercomprises identifying one or more procedures of interest for the user,creating one or more alerts for the one or more procedures of interestbased on a user preference, wherein the alerts include one or morekinematic risk factors and one or more kinematic mitigation factors.Additionally, the one or more alerts can be based on one or morethreshold limits set by the user, either during the initiation processor during a later adjustment. The method is adaptable such that the useran user change the one or more threshold limits at any time, includingduring evaluation of a particular patient's data. Typically, a summaryis provided to the user by a results viewer. In some aspects, theadditional steps of comparing the evaluation of the proposed procedureto the updated one or more threshold limits and providing an updatedsummary of one or more alerts for the one or more proposed procedures isalso contemplated. Additionally, one or more alerts can be allocated apriority and, in at least some configurations, the one or more alertscan be presented to the user in a sort based on the allocated priority.Additionally, risk mitigation factors are categorizable as at least oneor more of good, bad, and neutral. Moreover, in at least some aspects,the summary is displayed on an electronic device screen and furtherwherein the summary is displayed with one or more of each of videos,images, and tables. Additionally, the step of evaluating can furthercomprise evaluating one or more patient specific parameters. In at leastsome situations, the one or more patient specific parameters is one ormore parameter selected from the group comprising: demographics, height,weight, physical measurements, health history, symptoms, neurologicalexam results, co-morbidities.

Still another aspect of the disclosure is directed to a method forcomputer-assisted analysis of kinematic data. The computer-assistedmethod comprises, for example: aggregating kinematic data from two ormore patients into a database; encoding a kinematic evaluation algorithmas one or more decision trees, each decision tree further comprising,one or more decision points comprising one or more questions; and one ormore termination points, providing one or more images for a patient froman imaging system according to the algorithm; initiating an evaluationby identifying one or more proposed procedures for the patient;evaluating the proposed procedure applied to the one or more images fromthe imaging system and the database of aggregated data; comparing theevaluation of the proposed procedure to a user profile; and providing asummary of one or more alerts for the one or more proposed proceduresbased on the user profile and the one or more patient images.Additionally, the method can be performed on a communication network. Insome aspects, the method further comprises the steps of: creating a userprofile prior to the step of providing one or more images from animaging system wherein the step of creating further comprisesidentifying one or more procedures of interest for the user, creatingone or more alerts for the one or more procedures of interest based on auser preference, wherein the alerts include one or more kinematic riskfactors and one or more kinematic mitigation factors. Additionally, theone or more alerts can be based on one or more threshold limits set bythe user, either during the initiation process or during a lateradjustment. The method is adaptable such that the user an user changethe one or more threshold limits at any time, including duringevaluation of a particular patient's data. Typically, a summary isprovided to the user by a results viewer. In some aspects, theadditional steps of comparing the evaluation of the proposed procedureto the updated one or more threshold limits and providing an updatedsummary of one or more alerts for the one or more proposed procedures isalso contemplated. Additionally, one or more alerts can be allocated apriority and, in at least some configurations, the one or more alertscan be presented to the user in a sort based on the allocated priority.Additionally, risk mitigation factors are categorizable as at least oneor more of good, bad, and neutral. Moreover, in at least some aspects,the summary is displayed on an electronic device screen and furtherwherein the summary is displayed with one or more of each of videos,images, and tables. Additionally, the step of evaluating can furthercomprise evaluating one or more patient specific parameters. In at leastsome situations, the one or more patient specific parameters is one ormore parameter selected from the group comprising: demographics, height,weight, physical measurements, health history, symptoms, neurologicalexam results, co-morbidities.

Yet another aspect of the disclosure is directed to a system forevaluating kinematic data received from a patient. The system comprises:an imaging system adapted to capture one or more images of a targetjoint from a patient; a modeler adapted to provide a model of a targetbiomechanical behavior for the target joint; a comparer adapted tocompare the one or more images of the target joint with the computerimplemented model and generate resulting image. The system can include acommunication network through which various components of the systemcommunicate. The system can further comprising one or more of acomputer, a smart phone, and a tablet. Additionally, the system of claimcan further include a database of kinematic data. The database ofkinematic data can be from one or more patients. Additionally, a resultsviewer can be provided.

In still another aspect of the disclosure, a system for obtainingkinematic data from a patient is provided which comprises: an imagingsystem adapted to capture one or more images of a target joint from apatient; an apparatus for measuring joint motion comprising, a passivemotion device adapted and configured to continuously move a joint of thesubject through a range of motion, the passive motion device furthercomprising, a platform base, and a passive motion platform furthercomprising a static platform connected to an upper surface of theplatform base, a movable platform connected to at least one of thestatic platform or an upper surface of the platform base, wherein thestatic platform is adjacent the movable platform wherein movement of themovable platform is achieved in operation by a motor in communicationwith the moveable platform, and an imaging device adapted and configuredto image the joint of the subject during the motion of the passivemotion device, a comparer adapted to compare the one or more images ofthe target joint with the computer implemented model. The system caninclude a communication network through which various components of thesystem communicate. The system can further comprising one or more of acomputer, a smart phone, and a tablet. Additionally, the system of claimcan further include a database of kinematic data. The database ofkinematic data can be from one or more patients. Additionally, a resultsviewer can be provided.

Yet another aspect of the disclosure is directed to a surgical systemcomprising: an imaging system adapted to capture one or more images of atarget joint from a patient; an apparatus for measuring joint motioncomprising, a passive motion device adapted and configured tocontinuously move a joint of the subject through a range of motion, thepassive motion device further comprising, a platform base, and a passivemotion platform further comprising a static platform connected to anupper surface of the platform base, a movable platform connected to atleast one of the static platform or an upper surface of the platformbase, wherein the static platform is adjacent the movable platformwherein movement of the movable platform is achieved in operation by amotor in communication with the moveable platform, and an imaging deviceadapted and configured to image the joint of the subject during themotion of the passive motion device; and a device having a plurality ofarticulating arms having at least two articulation joints, thearticulating arms being adapted to be inserted into an operative spaceand further adapted to controllably articulate inside the operativespace, with at least three degrees of freedom of movement, at least oneaccess port adapted to receive the articulating arms, and a controlleradapted to control the articulation of the articulating arms inside theoperative space to perform a surgical procedure. The system can includea communication network through which various components of the systemcommunicate. The system can further comprising one or more of acomputer, a smart phone, and a tablet. Additionally, the system of claimcan further include a database of kinematic data. The database ofkinematic data can be from one or more patients. Additionally, a resultsviewer can be provided.

An aspect of the disclosure is directed to a method forcomputer-assisted analysis of kinematic data. Methods comprise: encodinga kinematic evaluation algorithm as one or more decision trees, eachdecision tree further comprising, one or more decision points comprisingone or more questions; and one or more termination points, providing oneor more images for a patient from an imaging system; initiating anevaluation by identifying one or more proposed procedures for thepatient; evaluating the proposed procedure applied to the one or moreimages from the imaging system according to the algorithm; comparing theevaluation of the proposed procedure to a user profile; and providing asummary of one or more alerts for the one or more proposed proceduresbased on the user profile and the one or more patient images.Additionally the method can be performed on a communication network,such as the Internet or an intranet using wired and wireless capability.Additional method steps can include, creating a user profile prior tothe step of providing one or more images from an imaging system whereinthe step of creating further comprises identifying one or moreprocedures of interest for the user, creating one or more alerts for theone or more procedures of interest based on a user preference, whereinthe alerts include one or more kinematic risk factors and one or morekinematic mitigation factors. In at least some instances, one or morealerts can be issued based on one or more threshold limits set by theuser. Users can also change the one or more threshold limits either at amail profile (thus impacting all cases or all future cases evaluated) orfor a specific case. Additionally, the summary is provided to the userby a results viewer. Additionally, the method can include comparing theevaluation of the proposed procedure to the updated one or morethreshold limits and providing an updated summary of one or more alertsfor the one or more proposed procedures. Moreover, the one or morealerts are allocated a priority and further wherein the one or morealerts are sorted based on the allocated priority. In some aspects, therisk mitigation factors are categorizable as at least one or more ofgood, bad, and neutral. Additionally, the summary is displayed on anelectronic device screen and further wherein the summary is displayedwith one or more of each of videos, images, and tables. The step ofevaluating can further comprise evaluating one or more patient specificparameters. Suitable patient parameters include, for example, one ormore parameter selected from the group comprising: demographics, height,weight, physical measurements, health history, symptoms, neurologicalexam results, co-morbidities.

Another aspect of the disclosure is directed to a method forcomputer-assisted analysis of kinematic data where the method comprises:aggregating kinematic data from two or more patients into a database;encoding a kinematic evaluation algorithm as one or more decision trees,each decision tree further comprising, one or more decision pointscomprising one or more questions; and one or more termination points,providing one or more images for a patient from an imaging systemaccording to the algorithm; initiating an evaluation by identifying oneor more proposed procedures for the patient; evaluating the proposedprocedure applied to the one or more images from the imaging system andthe database of aggregated data; comparing the evaluation of theproposed procedure to a user profile; and providing a summary of one ormore alerts for the one or more proposed procedures based on the userprofile and the one or more patient images. Additionally the method canbe performed on a communication network, such as the Internet or anintranet using wired and wireless capability. Additional method stepscan include, creating a user profile prior to the step of providing oneor more images from an imaging system wherein the step of creatingfurther comprises identifying one or more procedures of interest for theuser, creating one or more alerts for the one or more procedures ofinterest based on a user preference, wherein the alerts include one ormore kinematic risk factors and one or more kinematic mitigationfactors. In at least some instances, one or more alerts can be issuedbased on one or more threshold limits set by the user. Users can alsochange the one or more threshold limits either at a mail profile (thusimpacting all cases or all future cases evaluated) or for a specificcase. Additionally, the summary is provided to the user by a resultsviewer. Additionally, the method can include comparing the evaluation ofthe proposed procedure to the updated one or more threshold limits andproviding an updated summary of one or more alerts for the one or moreproposed procedures. Moreover, the one or more alerts are allocated apriority and further wherein the one or more alerts are sorted based onthe allocated priority. In some aspects, the risk mitigation factors arecategorizable as at least one or more of good, bad, and neutral.Additionally, the summary is displayed on an electronic device screenand further wherein the summary is displayed with one or more of each ofvideos, images, and tables. The step of evaluating can further compriseevaluating one or more patient specific parameters. Suitable patientparameters include, for example, one or more parameter selected from thegroup comprising: demographics, height, weight, physical measurements,health history, symptoms, neurological exam results, co-morbidities.

Still another aspect of the disclosure is directed to a system forevaluating kinematic data from a patient. A suitable system comprises:an imaging system adapted to capture one or more images of a targetjoint from a patient; a modeler adapted to provide a model of a targetbiomechanical behavior for the target joint; a comparer adapted tocompare the one or more images of the target joint with the computerimplemented model and generate resulting image. The system can furtherbe configured to operate on or in conjunction with a communicationnetwork, such as the Internet or an intranet using wired and wirelesscapability. Additionally, the system can employ one or more of acomputer, a smart phone, and a tablet. Additionally, the system cancreate, access, and/or maintain a database of kinematic data. A resultsviewer can also be provided.

Yet another aspect of the disclosure is directed to a system forobtaining kinematic data from a patient wherein the system comprises: animaging system adapted to capture one or more images of a target jointfrom a patient; an apparatus for measuring joint motion comprising apassive motion device adapted and configured to continuously move ajoint of the subject through a range of motion, the passive motiondevice further comprising, a platform base, and a passive motionplatform further comprising a static platform connected to an uppersurface of the platform base, a movable platform connected to at leastone of the static platform or an upper surface of the platform base,wherein the static platform is adjacent the movable platform whereinmovement of the movable platform is achieved in operation by a motor incommunication with the moveable platform, and an imaging device adaptedand configured to image the joint of the subject during the motion ofthe passive motion device a comparer adapted to compare the one or moreimages of the target joint with the computer implemented model. Thesystem can further be configured to operate on or in conjunction with acommunication network, such as the Internet or an intranet using wiredand wireless capability. Additionally, the system can employ one or moreof a computer, a smart phone, and a tablet. Additionally, the system cancreate, access, and/or maintain a database of kinematic data. A resultsviewer can also be provided.

Another aspect of the disclosure is directed to a surgical system. Thesurgical system comprises, for example, an imaging system adapted tocapture one or more images of a target joint from a patient; anapparatus for measuring joint motion comprising, a passive motion deviceadapted and configured to continuously move a joint of the subjectthrough a range of motion, the passive motion device further comprising,a platform base, and a passive motion platform further comprising astatic platform connected to an upper surface of the platform base, amovable platform connected to at least one of the static platform or anupper surface of the platform base, wherein the static platform isadjacent the movable platform wherein movement of the movable platformis achieved in operation by a motor in communication with the moveableplatform, and an imaging device adapted and configured to image thejoint of the subject during the motion of the passive motion device; anda device having a plurality of articulating arms having at least twoarticulation joints, the articulating arms being adapted to be insertedinto an operative space and further adapted to controllably articulateinside the operative space, with at least three degrees of freedom ofmovement, at least one access port adapted to receive the articulatingarms, and a controller adapted to control the articulation of thearticulating arms inside the operative space to perform a surgicalprocedure. The surgical system can further be configured to operate onor in conjunction with a communication network, such as the Internet oran intranet using wired and wireless capability. Additionally, thesurgical system can employ one or more of a computer, a smart phone, anda tablet. Additionally, the surgical system can create, access, and/ormaintain a database of kinematic data. A results viewer can also beprovided.

An additional aspect of the disclosure is directed to an imaging systemcomprising: a motion device for continuously moving a mammalian joint;an imaging device mounted to a free floating, ballasted vertical plane,wherein the imaging device is moveable relative to the motion deviceduring use to maintain a target anatomy within a targeted field of view;and a connector adapted to connect the imaging device to the motiondevice such that the imaging device and motion device move together whenactivated. One or more actuators can also be provided that are incommunication with the processing system and adapted to reposition theimaging device in response to the instruction. Additionally, acollimator can be included. In some configurations, the system comprisesone or more motion sensors positionable on a patient and incommunication with one or more of the imaging device and one or morerecording sensors. In still other configurations, a processing systemfor processing information from the one or more motion sensors togenerate an instruction is provided. Additionally, one or more actuatorsin communication with the processing system and adapted to repositionthe imaging device and motion device in response to an instruction canbe provided. In some configurations, the instruction is at least one ofautomatically generated, semi-automatically generated, or manuallygenerated, or combinations thereof. Moreover, the connector can be aconnection rod.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A is a lateral view of a normal human spinal column; FIG. 1B isillustrates a human body with the planes of the body identified;

FIG. 2A is a block diagram showing a representative example of a logicdevice through which clinical data reporting can be achieved;

FIG. 2B is a block diagram of an exemplary computing environment throughwhich the clinical data reporting software interface and the surgicalnavigation and patient positioning can be achieved;

FIG. 2C is an illustrative architectural diagram showing some structurethat can be employed by devices through which the clinical datareporting software interface and the surgical navigation and patientpositioning can be achieved;

FIG. 3 is an exemplary diagram of a server in an implementation suitablefor use in a system where the clinical data reporting software interfaceand the surgical navigation and patient positioning can be achieved;

FIG. 4 is an exemplary diagram of a master system in an implementationsuitable for use in a system where the clinical data reporting softwareinterface and the surgical navigation and patient positioning can beachieved;

FIG. 5 is a block diagram showing the cooperation of exemplarycomponents of a system suitable for use in a system where the clinicaldata reporting software interface and the surgical navigation andpatient positioning can be achieved;

FIG. 6 is a simplified block diagram of an initialization step for theclinical data reporting software interface. This initialization step isperformed once by a user prior to a first use, and can be updated asneeded. In this step the user defines a list of procedures of interestand associated alerts based on risk factors and risk mitigation factors;

FIG. 7 a is a simplified block diagram of a step for interpretingresponse the clinical data reporting software interface. This step isperformed when a subject undergoes kinematic testing. Results whichindicate specific kinematic dysfunctions detected at, for example, eachspine level are interpreted based on threshold limits which are set andchanged interactively by the user;

FIGS. 7 b and 7 c illustrate pages a first and second page of a two-pageexample of one embodiment of the type of data collected as part of theinitialization step that each user undergoes prior to using the clinicaldata reporting software interface;

FIG. 7 d illustrates a screen shot of how alerts can be configuredduring the initialization process and then subsequently changed by theuser using the clinical data reporting software interface;

FIG. 7 e illustrates types of alerts that, for example, a spine surgeonmay want to be warned about using the clinical data reporting softwareinterface;

FIG. 7 f illustrates a screen shot for viewing results including movingvideo images along with templates, graph, and numeric data; that can bepart of the results viewing capability of the clinical data reportingsoftware interface;

FIG. 7 g is a screen shot illustrating the results viewing capability ofthe clinical data reporting software interface, which facilitates auser's interaction with quantitative data regarding the detection ofspecific kinematic dysfunctions;

FIG. 7 h is an example screen shot that illustrates the capability forviewing and interacting with surgeon alerts, as part of an alertscapability of the clinical data reporting software interface;

FIG. 8 a is a block diagram outlining a process within the clinical datareporting software interface for creating a centralized aggregatedatabase allowing for data input, viewing and querying that can be usedfor consideration and comparison of patient outcomes;

FIGS. 8 b, 8 c, and 8 d are three screens shot that illustrate how auser of the clinical data reporting software would interact with thesystem to input data, view, and query the aggregated database. In FIG. 8b, a user interface is shown. In FIG. 8 c a method for inputtingneurological exam results into the aggregated database is shown. FIG. 8d a method for inputting a patient's pain scores into the aggregateddatabase, as well as functionality that enables a user to select amongvarious outcomes assessments to be output, are shown.

FIG. 9 is a block diagram outlining a process within the clinical datareporting software interface of interacting with a computer model ofspine biomechanics based on patient-specific kinematic test datacollected from subjects in a standing or lying down position, allowingfor isolating muscle or load contribution which can help users furtherisolate the potential causes of joint pain or performance problems;

FIG. 10 is a block diagram showing system components andinter-connections of a surgical navigation and patient positioningsystem;

FIG. 11 is an illustration of a center of rotation report for a singlelevel in the spinal column, which could come from the measurement systemand be used as a parameter in optimizing the balance of the spinepost-operatively via deterministic geometry and orientation of asurgical construct accomplishable via a surgical navigation systemworking in combination with the surgical navigation and patientpositioning components;

FIG. 12 is a table illustrating ways in which functional targets couldbe clinically useful in a surgical navigation system, as enabled via thesurgical navigation and patient positioning;

FIG. 13 illustrates a first step of a two step process for achievingposition and geometry of a spine fusion surgical construct via thesurgical navigation and patient positioning; and

FIG. 14 illustrates a second step of a two step process for achievingposition and geometry of a spine fusion surgical construct via thesurgical navigation and patient positioning; and

FIG. 15 is a block diagram of an imaging system moveable within avertical plane, operating in manual mode;

FIG. 16 is a block diagram of an imaging system moveable within avertical plane, operating in automatic mode; and

FIGS. 17A-B illustrate the functionality of a collimator device and acollimator in conjunction with a patient examination table suitable foruse with this system.

DETAILED DESCRIPTION OF THE INVENTION I. Anatomical Context

FIG. 1 illustrates the human spinal column 10 which is comprised of aseries of thirty-three stacked vertebrae 12 divided into five regions.The cervical region includes seven vertebrae, known as C1-C7. Thethoracic region includes twelve vertebrae, known as T1-T12. The lumbarregion contains five vertebrae, known as L1-L5. The sacral region iscomprised of five fused vertebrae, known as S1-S5, while the coccygealregion contains four fused vertebrae, known as Co1-Co4.

In order to understand the configurability, adaptability, andoperational aspects of the systems, methods and devices disclosedherein, it is helpful to understand the anatomical references of thebody 50 with respect to which the position and operation of the devices,and components thereof, are described. As shown in FIG. 1B, there arethree anatomical planes generally used in anatomy to describe the humanbody and structure within the human body: the axial plane 52, thesagittal plane 54 and the coronal plane 56. Additionally, devices andthe operation of devices and tools may be better understood with respectto the caudad 60 direction and/or the cephalad direction 62. Devices andtools can be positioned dorsally 70 (or posteriorly) such that theplacement or operation of the device is toward the back or rear of thebody. Alternatively, devices can be positioned ventrally 72 (oranteriorly) such that the placement or operation of the device is towardthe front of the body. Various embodiments of the devices, systems andtools of the present disclosure may be configurable and variable withrespect to a single anatomical plane or with respect to two or moreanatomical planes. For example, a subject or a feature of the device maybe described as lying within and having adaptability or operability inrelation to a single plane. A device may be positioned in a desiredlocation relative to a sagittal plane and may be moveable between anumber of adaptable positions or within a range of positions.

For purposes of illustration, the devices and methods of the disclosureare described below with reference to the spine of the human body.However, as will be appreciation by those skilled in the art, thedevices and methods can be employed to address any effected bone orjoint, including, for example, the hip, the knee, the ankle, the wrist,the elbow, and the shoulder. Additionally, the devices and methods canalso be employed with any mammal.

II. Computing Systems

The systems and methods described herein rely on a variety of computersystems, networks and/or digital devices for operation. In order tofully appreciate how the system operates an understanding of suitablecomputing systems is useful. The systems and methods disclosed hereinare enabled as a result of application via a suitable computing system.

FIG. 2A is a block diagram showing a representative example logic devicethrough which a browser can be accessed to implement the presentdisclosure. A computer system (or digital device) 100, which may beunderstood as a logic apparatus adapted and configured to readinstructions from media 114 and/or network port 106, is connectable to aserver 110, and has a fixed media 116. The computer system 100 can alsobe connected to the Internet or an intranet. The system includes centralprocessing unit (CPU) 102, disk drives 104, optional input devices,illustrated as keyboard 118 and/or mouse 120 and optional monitor 108.Data communication can be achieved through, for example, communicationmedium 109 to a server 110 at a local or a remote location. Thecommunication medium 109 can include any suitable mechanism fortransmitting and/or receiving data. For example, the communicationmedium can be a network connection, a wireless connection or an internetconnection. It is envisioned that data relating to the presentdisclosure can be transmitted over such networks or connections. Thecomputer system can be adapted to communicate with a participant and/ora device used by a participant. The computer system is adaptable tocommunicate with other computers over the Internet, or with computersvia a server.

FIG. 2B depicts another exemplary computing system 100. The computingsystem 100 is capable of executing a variety of computing applications138, including computing applications, a computing applet, a computingprogram, or other instructions for operating on computing system 100 toperform at least one function, operation, and/or procedure. Computingsystem 100 is controllable by computer readable storage media fortangibly storing computer readable instructions, which may be in theform of software. The computer readable storage media adapted totangibly store computer readable instructions can contain instructionsfor computing system 100 for storing and accessing the computer readablestorage media to read the instructions stored thereon themselves. Suchsoftware may be executed within CPU 102 to cause the computing system100 to perform desired functions. In many known computer servers,workstations and personal computers CPU 102 is implemented bymicro-electronic chips CPUs called microprocessors. Optionally, aco-processor, distinct from the main CPU 102, can be provided thatperforms additional functions or assists the CPU 102. The CPU 102 may beconnected to co-processor through an interconnect. One common type ofcoprocessor is the floating-point coprocessor, also called a numeric ormath coprocessor, which is designed to perform numeric calculationsfaster and better than the general-purpose CPU 102.

As will be appreciated by those skilled in the art, a computer readablemedium stores computer data, which data can include computer programcode that is executable by a computer, in machine readable form. By wayof example, and not limitation, a computer readable medium may comprisecomputer readable storage media, for tangible or fixed storage of data,or communication media for transient interpretation of code-containingsignals. Computer readable storage media, as used herein, refers tophysical or tangible storage (as opposed to signals) and includeswithout limitation volatile and non-volatile, removable andnon-removable storage media implemented in any method or technology forthe tangible storage of information such as computer-readableinstructions, data structures, program modules or other data. Computerreadable storage media includes, but is not limited to, RAM, ROM, EPROM,EEPROM, flash memory or other solid state memory technology, CD-ROM,DVD, or other optical storage, magnetic cassettes, magnetic tape,magnetic disk storage or other magnetic storage devices, or any otherphysical or material medium which can be used to tangibly store thedesired information or data or instructions and which can be accessed bya computer or processor

In operation, the CPU 102 fetches, decodes, and executes instructions,and transfers information to and from other resources via the computer'smain data-transfer path, system bus 140. Such a system bus connects thecomponents in the computing system 100 and defines the medium for dataexchange. Memory devices coupled to the system bus 140 include randomaccess memory (RAM) 124 and read only memory (ROM) 126. Such memoriesinclude circuitry that allows information to be stored and retrieved.The ROMs 126 generally contain stored data that cannot be modified. Datastored in the RAM 124 can be read or changed by CPU 102 or otherhardware devices. Access to the RAM 124 and/or ROM 126 may be controlledby memory controller 122. The memory controller 122 may provide anaddress translation function that translates virtual addresses intophysical addresses as instructions are executed.

In addition, the computing system 100 can contain peripherals controller128 responsible for communicating instructions from the CPU 102 toperipherals, such as, printer 142, keyboard 118, mouse 120, and datastorage drive 143. Display 108, which is controlled by a displaycontroller 163, is used to display visual output generated by thecomputing system 100. Such visual output may include text, graphics,animated graphics, and video. The display controller 134 includeselectronic components required to generate a video signal that is sentto display 108. Further, the computing system 100 can contain networkadaptor 136 which may be used to connect the computing system 100 to anexternal communications network 132.

III. Networks and Internet Protocol

As is well understood by those skilled in the art, the Internet is aworldwide network of computer networks. Today, the Internet is a publicand self-sustaining network that is available to many millions of users.The Internet uses a set of communication protocols called TCP/IP (i.e.,Transmission Control Protocol/Internet Protocol) to connect hosts. TheInternet has a communications infrastructure known as the Internetbackbone. Access to the Internet backbone is largely controlled byInternet Service Providers (ISPs) that resell access to corporations andindividuals.

The Internet Protocol (IP) enables data to be sent from one device(e.g., a phone, a Personal Digital Assistant (PDA), a computer, etc.) toanother device on a network. There are a variety of versions of IPtoday, including, e.g., IPv4, IPv6, etc. Other IPs are no doubtavailable and will continue to become available in the future, any ofwhich can be used without departing from the scope of the disclosure.Each host device on the network has at least one IP address that is itsown unique identifier and acts as a connectionless protocol. Theconnection between end points during a communication is not continuous.When a user sends or receives data or messages, the data or messages aredivided into components known as packets. Every packet is treated as anindependent unit of data and routed to its final destination—but notnecessarily via the same path.

The Open System Interconnection (OSI) model was established tostandardize transmission between points over the Internet or othernetworks. The OSI model separates the communications processes betweentwo points in a network into seven stacked layers, with each layeradding its own set of functions. Each device handles a message so thatthere is a downward flow through each layer at a sending end point andan upward flow through the layers at a receiving end point. Theprogramming and/or hardware that provides the seven layers of functionis typically a combination of device operating systems, applicationsoftware, TCP/IP and/or other transport and network protocols, and othersoftware and hardware.

Typically, the top four layers are used when a message passes from or toa user and the bottom three layers are used when a message passesthrough a device (e.g., an IP host device). An IP host is any device onthe network that is capable of transmitting and receiving IP packets,such as a server, a router or a workstation. Messages destined for someother host are not passed up to the upper layers but are forwarded tothe other host. The layers of the OSI model are listed below. Layer 7(i.e., the application layer) is a layer at which, e.g., communicationpartners are identified, quality of service is identified, userauthentication and privacy are considered, constraints on data syntaxare identified, etc. Layer 6 (i.e., the presentation layer) is a layerthat, e.g., converts incoming and outgoing data from one presentationformat to another, etc. Layer 5 (i.e., the session layer) is a layerthat, e.g., sets up, coordinates, and terminates conversations,exchanges and dialogs between the applications, etc. Layer-4 (i.e., thetransport layer) is a layer that, e.g., manages end-to-end control anderror-checking, etc. Layer-3 (i.e., the network layer) is a layer that,e.g., handles routing and forwarding, etc. Layer-2 (i.e., the data-linklayer) is a layer that, e.g., provides synchronization for the physicallevel, does bit-stuffing and furnishes transmission protocol knowledgeand management, etc. The Institute of Electrical and ElectronicsEngineers (IEEE) sub-divides the data-link layer into two furthersub-layers, the MAC (Media Access Control) layer that controls the datatransfer to and from the physical layer and the LLC (Logical LinkControl) layer that interfaces with the network layer and interpretscommands and performs error recovery. Layer 1 (i.e., the physical layer)is a layer that, e.g., conveys the bit stream through the network at thephysical level. The IEEE sub-divides the physical layer into the PLCP(Physical Layer Convergence Procedure) sub-layer and the PMD (PhysicalMedium Dependent) sub-layer.

IV. Wireless Networks

Wireless networks can incorporate a variety of types of mobile devices,such as, e.g., cellular and wireless telephones, PCs (personalcomputers), laptop computers, wearable computers, cordless phones,pagers, headsets, printers, PDAs, etc. For example, mobile devices mayinclude digital systems to secure fast wireless transmissions of voiceand/or data. Typical mobile devices include some or all of the followingcomponents: a transceiver (for example a transmitter and a receiver,including a single chip transceiver with an integrated transmitter,receiver and, if desired, other functions); an antenna; a processor;display; one or more audio transducers (for example, a speaker or amicrophone as in devices for audio communications); electromagnetic datastorage (such as ROM, RAM, digital data storage, etc., such as indevices where data processing is provided); memory; flash memory; and/ora full chip set or integrated circuit; interfaces (such as universalserial bus (USB), coder-decoder (CODEC), universal asynchronousreceiver-transmitter (UART), phase-change memory (PCM), etc.). Othercomponents can be provided without departing from the scope of thedisclosure.

Wireless LANs (WLANs) in which a mobile user can connect to a local areanetwork (LAN) through a wireless connection may be employed for wirelesscommunications. Wireless communications can include communications thatpropagate via electromagnetic waves, such as light, infrared, radio, andmicrowave. There are a variety of WLAN standards that currently exist,such as Bluetooth®, IEEE 802.11, and the obsolete HomeRF.

By way of example, Bluetooth products may be used to provide linksbetween mobile computers, mobile phones, portable handheld devices,personal digital assistants (PDAs), and other mobile devices andconnectivity to the Internet. Bluetooth is a computing andtelecommunications industry specification that details how mobiledevices can easily interconnect with each other and with non-mobiledevices using a short-range wireless connection. Bluetooth creates adigital wireless protocol to address end-user problems arising from theproliferation of various mobile devices that need to keep datasynchronized and consistent from one device to another, thereby allowingequipment from different vendors to work seamlessly together.

An IEEE standard, IEEE 802.11, specifies technologies for wireless LANsand devices. Using 802.11, wireless networking may be accomplished witheach single base station supporting several devices. In some examples,devices may come pre-equipped with wireless hardware or a user mayinstall a separate piece of hardware, such as a card, that may includean antenna. By way of example, devices used in 802.11 typically includethree notable elements, whether or not the device is an access point(AP), a mobile station (STA), a bridge, a personal computing memory cardInternational Association (PCMCIA) card (or PC card) or another device:a radio transceiver; an antenna; and a MAC (Media Access Control) layerthat controls packet flow between points in a network.

In addition, Multiple Interface Devices (MIDs) may be utilized in somewireless networks. MIDs may contain two independent network interfaces,such as a Bluetooth interface and an 802.11 interface, thus allowing theMID to participate on two separate networks as well as to interface withBluetooth devices. The MID may have an IP address and a common IP(network) name associated with the IP address.

Wireless network devices may include, but are not limited to Bluetoothdevices, WiMAX (Worldwide Interoperability for Microwave Access),Multiple Interface Devices (MIDs), 802.11x devices (IEEE 802.11 devicesincluding, 802.11a, 802.11b and 802.11g devices), HomeRF (Home RadioFrequency) devices, Wi-Fi (Wireless Fidelity) devices, GPRS (GeneralPacket Radio Service) devices, 3 G cellular devices, 2.5 G cellulardevices, GSM (Global System for Mobile Communications) devices, EDGE(Enhanced Data for GSM Evolution) devices, TDMA type (Time DivisionMultiple Access) devices, or CDMA type (Code Division Multiple Access)devices, including CDMA2000. Each network device may contain addressesof varying types including but not limited to an IP address, a BluetoothDevice Address, a Bluetooth Common Name, a Bluetooth IP address, aBluetooth IP Common Name, an 802.11 IP Address, an 802.11 IP commonName, or an IEEE MAC address.

Wireless networks can also involve methods and protocols found in,Mobile IP (Internet Protocol) systems, in PCS systems, and in othermobile network systems. With respect to Mobile IP, this involves astandard communications protocol created by the Internet EngineeringTask Force (IETF). With Mobile IP, mobile device users can move acrossnetworks while maintaining their IP Address assigned once. See Requestfor Comments (RFC) 3344. NB: RFCs are formal documents of the InternetEngineering Task Force (IETF). Mobile IP enhances Internet Protocol (IP)and adds a mechanism to forward Internet traffic to mobile devices whenconnecting outside their home network. Mobile IP assigns each mobilenode a home address on its home network and a care-of-address (CoA) thatidentifies the current location of the device within a network and itssubnets. When a device is moved to a different network, it receives anew care-of address. A mobility agent on the home network can associateeach home address with its care-of address. The mobile node can send thehome agent a binding update each time it changes its care-of addressusing Internet Control Message Protocol (ICMP).

In basic IP routing (e.g., outside mobile IP), routing mechanisms relyon the assumptions that each network node has a constant attachmentpoint to the Internet and that each node's IP address identifies thenetwork link it is attached to. In this document, the terminology “node”includes a connection point, which can include a redistribution point oran end point for data transmissions, and which can recognize, processand/or forward communications to other nodes. For example, Internetrouters can look at an IP address prefix or the like identifying adevice's network. Then, at a network level, routers can look at a set ofbits identifying a particular subnet. Then, at a subnet level, routerscan look at a set of bits identifying a particular device. With typicalmobile IP communications, if a user disconnects a mobile device from theInternet and tries to reconnect it at a new subnet, then the device hasto be reconfigured with a new IP address, a proper netmask and a defaultrouter. Otherwise, routing protocols would not be able to deliver thepackets properly.

FIG. 2C depicts components that can be employed in system configurationsenabling the systems and technical effect of this disclosure, includingwireless access points to which client devices communicate. In thisregard, FIG. 2C shows a wireless network 150 connected to a wirelesslocal area network (WLAN) 152. The WLAN 152 includes an access point(AP) 154 and a number of user stations 156, 156′. For example, thenetwork 150 can include the Internet or a corporate data processingnetwork. The access point 154 can be a wireless router, and the userstations 156, 156′ can be portable computers, personal desk-topcomputers, PDAs, portable voice-over-IP telephones and/or other devices.The access point 154 has a network interface 158 linked to the network150, and a wireless transceiver in communication with the user stations156, 156′. For example, the wireless transceiver 160 can include anantenna 162 for radio or microwave frequency communication with the userstations 156, 156′. The access point 154 also has a processor 164, aprogram memory 166, and a random access memory 168. The user station 156has a wireless transceiver 170 including an antenna 172 forcommunication with the access point station 154. In a similar fashion,the user station 156′ has a wireless transceiver 170′ and an antenna 172for communication to the access point 154. By way of example, in someembodiments an authenticator could be employed within such an accesspoint (AP) and/or a supplicant or peer could be employed within a mobilenode or user station. Desktop 108 and key board 118 or input devices canalso be provided with the user status.

V. Media Independent Handover Services

In IEEE P802.21/D.01.09, September 2006, entitled Draft IEEE Standardfor Local and Metropolitan Area Networks: Media Independent HandoverServices, among other things, the document specifies 802 mediaaccess-independent mechanisms that optimize handovers between 802systems and cellular systems. The IEEE 802.21 standard definesextensible media access independent mechanisms that enable theoptimization of handovers between heterogeneous 802 systems and mayfacilitate handovers between 802 systems and cellular systems. “Thescope of the IEEE 802.21 (Media Independent Handover) standard is todevelop a specification that provides link layer intelligence and otherrelated network information to upper layers to optimize handoversbetween heterogeneous media. This includes links specified by 3GPP,3GPP2 and both wired and wireless media in the IEEE 802 family ofstandards. Note, in this document, unless otherwise noted, “media”refers to method/mode of accessing a telecommunication system (e.g.cable, radio, satellite, etc.), as opposed to sensory aspects ofcommunication (e.g. audio, video, etc.).” See 1.1 of I.E.E.E.P802.21/D.01.09, September 2006, entitled Draft IEEE Standard for Localand Metropolitan Area Networks Media Independent Handover Services, theentire contents of which document is incorporated herein into and aspart of this patent application. Other IEEE, or other such standards onprotocols can be relied on as appropriate or desirable.

FIG. 3 is an exemplary diagram of a server 210 in an implementationconsistent with the principles of the disclosure to achieve the desiredtechnical effect and transformation. Server 210 may include a bus 240, aprocessor 202, a local memory 244, one or more optional input units 246,one or more optional output units 248, a communication interface 232,and a memory interface 222. Bus 240 may include one or more conductorsthat permit communication among the components of chunk server 250.

Processor 202 may include any type of conventional processor ormicroprocessor that interprets and executes instructions. Local memory244 may include a random access memory (RAM) or another type of dynamicstorage device that stores information and instructions for execution byprocessor 202 and/or a read only memory (ROM) or another type of staticstorage device that stores static information and instructions for useby processor 202.

Input unit 246 may include one or more conventional mechanisms thatpermit an operator to input information to a server 110, such as akeyboard 118, a mouse 120 (shown in FIG. 2), a pen, voice recognitionand/or biometric mechanisms, etc. Output unit 248 may include one ormore conventional mechanisms that output information to the operator,such as a display 134, a printer 130 (shown in FIG. 2), a speaker, etc.Communication interface 232 may include any transceiver-like mechanismthat enables chunk server 250 to communicate with other devices and/orsystems. For example, communication interface 232 may include mechanismsfor communicating with master and clients.

Memory interface 222 may include a memory controller 122. Memoryinterface 222 may connect to one or more memory devices, such as one ormore local disks 274, and control the reading and writing of chunk datato/from local disks 276. Memory interface 222 may access chunk datausing a chunk handle and a byte range within that chunk.

FIG. 4 is an exemplary diagram of a master system 376 suitable for usein an implementation consistent with the principles of the disclosure toachieve the desired technical effect and transformation. Master system376 may include a bus 340, a processor 302, a main memory 344, a ROM326, a storage device 378, one or more input devices 346, one or moreoutput devices 348, and a communication interface 332. Bus 340 mayinclude one or more conductors that permit communication among thecomponents of master system 374.

Processor 302 may include any type of conventional processor ormicroprocessor that interprets and executes instructions. Main memory344 may include a RAM or another type of dynamic storage device thatstores information and instructions for execution by processor 302. ROM326 may include a conventional ROM device or another type of staticstorage device that stores static information and instructions for useby processor 302. Storage device 378 may include a magnetic and/oroptical recording medium and its corresponding drive. For example,storage device 378 may include one or more local disks that providepersistent storage.

Input devices 346 used to achieve the desired technical effect andtransformation may include one or more conventional mechanisms thatpermit an operator to input information to the master system 374, suchas a keyboard 118, a mouse 120, (shown in FIG. 2) a pen, voicerecognition and/or biometric mechanisms, etc. Output devices 348 mayinclude one or more conventional mechanisms that output information tothe operator, including a display 108, a printer 142 (shown in FIG. 1),a speaker, etc. Communication interface 332 may include anytransceiver-like mechanism that enables master system 374 to communicatewith other devices and/or systems. For example, communication interface332 may include mechanisms for communicating with servers and clients asshown above.

Master system 376 used to achieve the desired technical effect andtransformation may maintain file system metadata within one or morecomputer readable mediums, such as main memory 344 and/or storagedevice.

The computer implemented system provides a storage and delivery basewhich allows users to exchange services and information openly on theInternet used to achieve the desired technical effect andtransformation. A user will be enabled to operate as both a consumer andproducer of any and all digital content or information through one ormore master system servers.

A user executes a browser to view digital content items and can connectto the front end server via a network, which is typically the Internet,but can also be any network, including but not limited to anycombination of a LAN, a MAN, a WAN, a mobile, wired or wireless network,a private network, or a virtual private network. As will be understood,a very large numbers (e.g., millions) of users are supported and can bein communication with the website at any time. The user may include avariety of different computing devices. Examples of user devicesinclude, but are not limited to, personal computers, digital assistants,personal digital assistants, cellular phones, mobile phones, smartphones or laptop computers.

The browser can include any application that allows users to access webpages on the World Wide Web. Suitable applications include, but are notlimited to, Microsoft Internet Explorer®, Netscape Navigator®, Mozilla®Firefox, Apple® Safari or any application adapted to allow access to webpages on the World Wide Web. The browser can also include a video player(e.g., Flash™ from Adobe Systems, Inc.), or any other player adapted forthe video file formats used in the video hosting website. Alternatively,videos can be accessed by a standalone program separate from thebrowser. A user can access a video from the website by, for example,browsing a catalog of digital content, conducting searches on keywords,reviewing aggregate lists from other users or the system administrator(e.g., collections of videos forming channels), or viewing digitalcontent associated with particular user groups (e.g., communities).

VI. Computer Network Environment

Computing system 100, described above, can be deployed as part of acomputer network used to achieve the desired technical effect andtransformation. In general, the above description for computingenvironments applies to both server computers and client computersdeployed in a network environment. FIG. 5 illustrates an exemplaryillustrative networked computing environment 400, with a server incommunication with client computers via a communications network 450. Asshown in FIG. 5, server 410 may be interconnected via a communicationsnetwork 450 (which may be either of, or a combination of a fixed-wire orwireless LAN, WAN, intranet, extranet, peer-to-peer network, virtualprivate network, the Internet, or other communications network) with anumber of client computing environments such as tablet personal computer402, mobile telephone 404, telephone 406, personal computer 402, andpersonal digital assistant 408. In a network environment in which thecommunications network 450 is the Internet, for example, server 410 canbe dedicated computing environment servers operable to process andcommunicate data to and from client computing environments via any of anumber of known protocols, such as, hypertext transfer protocol (HTTP),file transfer protocol (FTP), simple object access protocol (SOAP), orwireless application protocol (WAP). Other wireless protocols can beused without departing from the scope of the disclosure, including, forexample Wireless Markup Language (WML), DoCoMo i-mode (used, forexample, in Japan) and XHTML Basic. Additionally, networked computingenvironment 400 can utilize various data security protocols such assecured socket layer (SSL) or pretty good privacy (PGP). Each clientcomputing environment can be equipped with operating system 438 operableto support one or more computing applications, such as a web browser(not shown), or other graphical user interface (not shown), or a mobiledesktop environment (not shown) to gain access to server computingenvironment 400.

In operation, a user (not shown) may interact with a computingapplication running on a client computing environment to obtain desireddata and/or computing applications. The data and/or computingapplications may be stored on server computing environment 400 andcommunicated to cooperating users through client computing environmentsover exemplary communications network 450. The computing applications,described in more detail below, are used to achieve the desiredtechnical effect and transformation set forth. A participating user mayrequest access to specific data and applications housed in whole or inpart on server computing environment 400. These data may be communicatedbetween client computing environments and server computing environmentsfor processing and storage. Server computing environment 400 may hostcomputing applications, processes and applets for the generation,authentication, encryption, and communication data and applications andmay cooperate with other server computing environments (not shown),third party service providers (not shown), network attached storage(NAS) and storage area networks (SAN) to realize application/datatransactions.

VII. Media Independent Information Service

The Media Independent Information Service (MIIS) provides a frameworkand corresponding mechanisms by which an MIHF entity may discover andobtain network information existing within a geographical area tofacilitate handovers. Additionally or alternatively, neighboring networkinformation discovered and obtained by this framework and mechanisms canalso be used in conjunction with user and network operator policies foroptimum initial network selection and access (attachment), or networkre-selection in idle mode.

MIIS primarily provides a set of information elements (IEs), theinformation structure and its representation, and a query/response typeof mechanism for information transfer. The information can be present insome information server from which, e.g., an MIHF in the Mobile Node(MN) can access it.

Depending on the type of mobility, support for different types ofinformation elements may be necessary for performing handovers. MIISprovides the capability for obtaining information about lower layerssuch as neighbor maps and other link layer parameters, as well asinformation about available higher layer services such as Internetconnectivity.

MIIS provides a generic mechanism to allow a service provider and amobile user to exchange information on different handover candidateaccess networks. The handover candidate information can includedifferent access technologies such as IEEE 802 networks, 3GPP networksand 3GPP2 networks. The MIIS also allows this collective information tobe accessed from any single network. For example, by using an IEEE802.11 access network, it can be possible to get information not onlyabout all other IEEE 802 based networks in a particular region but alsoabout 3GPP and 3GPP2 networks. Similarly, using, e.g., a 3GPP2interface, it can be possible to get access to information about allIEEE 802 and 3GPP networks in a given region. This capability allows theMN to use its currently active access network and inquire about otheravailable access networks in a geographical region. Thus, a MN is freedfrom the burden of powering up each of its individual radios andestablishing network connectivity for the purpose of retrievingheterogeneous network information. MIIS enables this functionalityacross all available access networks by providing a uniform way toretrieve heterogeneous network information in any geographical area.

VIII. Software Programs Implementable in the Computing and NetworkEnvironments to Achieve a Desired Technical Effect or Transformation

A. Clinical Data Reporting Software Interface

A clinical data reporting software interface comprises a communicationsnetwork, communication medium, input and output devices, computingapplication and software application that communicate and compute datathrough a process of initialization by user, interpretation of results,and comparison with aggregated data.

The clinical data reporting software interface integrates userpreferences for procedures of interest along with associated riskfactors and risk mitigation factors to facilitate interpretation ofpatient specific results for specific kinematic dysfunctions, at eachspine level. A user profile is also created during the initializationstep and generally does not change from patient-to-patient for aparticular user, however this profile is changeable by the user.

FIG. 6 is a simplified block diagram of an initialization process forthe clinical data reporting software interface which is performed onceby the user, and can be updated as needed. In this step the user definesa list of one or more procedures of interest 610, e.g., Procedure 1 612,Procedure 2 614 through Procedure N 616. These procedures can representa range of potential surgeries that a given user commonly prescribes tohis or her patients. Once the list of procedures of interest for a givenuser is defined, then associated alerts 620 are also defined for eachprocedures based on one or more kinematic risk factors and one or morekinematic risk mitigation factors associated with each procedure. Forexample, the user would define one or more kinematic risk factors 622,624, 626 corresponding to each of the procedures 612, 614, 616 as wellas one or more kinematic risk mitigation factors 623, 625, 627corresponding to each of the procedures. In some aspects, a particularprocedure may have no mitigation factors and no risk factors, one ormore mitigation factors and no risk factors, no mitigation factors andone or more risk factors, or one or more mitigation factors and one ormore risk factors. For purposes of illustration, FIG. 7 e providesexamples of kinematic risk factors and kinematic risk mitigation factorsfor some commonly prescribed spine surgeries.

The process of analyzing and interpreting results within the clinicaldata reporting software interface is performed each time a subject(patient) undergoes kinematic testing. The results for each subjecttested indicates one or more specific kinematic dysfunctions that havebeen detected. In the context of the spine, the one or more dysfunctionscan be provided at each spine level. The combination of risk and riskmitigation factors are defined as specific alerts in the reportingsystem that can be presented to the user (surgeon) for evaluation ofchanges to a planned procedure for a particular patient.

FIG. 7 a is a block diagram illustrating the process of interpretingresults within the clinical data reporting software interface. Forexample, the measurement system 719 communicates kinematic testingresults for each patient 720. The kinematic testing results can be, forexample, an identification of specific kinematic dysfunctions that havebeen detected at each spine level. Based on the kinetic testing results720 a list of alerts for each procedure being considered is generated726 which takes into consideration the user (physician) profile createdduring the initialization process 722 and a list of specific proceduresbeing considered for the particular patient 730. The alerts arepresented to the clinician 728 at which point the clinician can changethe threshold limits for detecting kinematic dysfunctions for thatpatient 724, or change a list of procedures being considered 732.Results of this process are presented to the user via the results viewer721.

FIGS. 7 b and 7 c show a first and second page of a two-page sample formthat represents one embodiment of data a user (e.g., surgeon) wouldprovide during the initialization process, the data from which would bepart of the user profile described above with respect to FIG. 6.

FIG. 7 d is a screen shot 730 which illustrates how the alerts that areconfigured during the initialization process can be changed by the userusing the clinical data reporting interface. In this figure, the usercan construct alerts using drop down menus and check boxes, viewexisting alerts, assign priority to alerts, edit alerts, delete alerts,and specify the exact configuration of the alerts with respect to whichbending mode the alert is based on. Any changes made would then be savedin the user profile.

FIG. 7 e shows the types of alerts that, according to one embodiment, aspine surgeon may want to be warned about, both in terms of “Good” and“Bad” risk mitigation factors alerts based on the user profile set-upduring the initiation process.

Additionally, users can view kinematic testing results via the resultsviewer. Moreover, the results viewer allows for multiple types ofresults viewing, including the viewing of moving video images along withtemplates, graph, and numeric data, as depicted in the screen shot 740presented as FIG. 7 f. As illustrated in FIG. 7 f, moving medical imagescan be played as an image sequence, and displayed alongside graph datadepicting the relative motion between anatomical landmarks across a setof moving images, wherein a cursor (a vertical line in this case) movesacross the graphs showing the point on each graph that corresponds tothe specific image frame being presented. Template data, showing themeasured position of each tracked landmark on the moving imagesequences, is also displayed by being overlaid on top of each individualframe of the moving image sequences, such that the user can confirm thatthe templates are placed appropriately on the anatomical landmarks aboutwhich relative motion data is being presented. Additional quantitativedata is presented alongside the graphs and image sequences. Differentdata from different bending modes can be accessed via this capability,and the user is provided with tools to let them determine which data toview.

The results viewer also enables a user to interact with quantitativedata regarding the detection of specific kinematic dysfunctions. FIG. 7g shows a screen shot 750 representing an example of this capability. Inthis figure, the results viewer affords the user several analyticcapabilities, such as the ability to vary the statistical thresholdlimits with which abnormalities are detected. For example, if a “Falsepositive rate” is set to 5%, only patients below 2.5^(th) percentile orabove 97.5^(th) percentile (relative to a normative dataset collectedfrom asymptomatic subjects) would be considered abnormal. If this “falsepositive rate” were to be changed to 10%, the threshold limits wouldthen change to below the 5^(th) percentile or above the 95^(th)percentile, and so on. Another capability is to present graphic iconswhich represent specific kinematic abnormalities, then either presentingthese icons or not depending on whether the abnormality is detectedbased on the specific threshold limit set by the user. Anothercapability is to view measurement data graphically and numerically.Different data from different bending modes can be accessed via thiscapability, and the user is provided with tools to let them determinewhich data to view.

As shown in FIG. 7G alerts can be presented to the user as a graphicpresentation. An embodiment of this capability is represented in thescreen shot 760. As described above, the statistical threshold limitswith which abnormalities are detected can be varied by the user, and theresulting changes to the list of surgical alerts which are triggered arepresented to the user in real time.

The clinical data reporting software system provides a process ofcreating a centralized aggregate database allowing for data input,viewing and querying that can be used by the user to compare potentialclinical outcomes of the subjects.

FIG. 8 a is a simplified block diagram outlining the process andmechanism for inputting additional data on each subject to include, suchdata to include: demographic, height/weight/other physical measurements,subject history, symptoms, neurological exam results, otherco-morbidities at each level, other systemic patient co-morbidities(such as diabetes, for example), prior procedures performed and theirrelated outcome(s), as well as other parameters, and a process fortransmitting this additional data to an aggregated database. The systemprovides a process for collecting data from all subjects tested,creating an aggregated database that can be used for consideration andcomparison of outcomes for subjects matched based on: 1) kinematicpresentation, 2) additional data collected, and 3) procedure beingconsidered. The predicted outcome data is presented to the user and canbe used to modify inputs to start the process over again with a newseries of inputs if desired.

For patients who get tested, there is an additional process that allowsthe user (surgeon/clinician) to input additional data, then view dataregarding potential clinical outcomes of procedures being considered byquerying the aggregated database. Kinematic testing results for eachpatient, which indicates the specific kinematic dysfunction that hasbeen detected, for example, at each spine level 820 communicates with aquery aggregated database 840 to determine outcomes for patients matchedbased on kinematic presentation, additional data collected on thepatient, and the procedure being considered. The user can change thelist of procedures being considered 832 which changes the list ofspecific procedures being considered for a specific patient 830 which inturn impacts the list of alerts generated for each procedure beingconsidered 826. The list of alerts 826 also factors in the user profilefrom the initialization process 822. When alerts are presented to theuser 828 it is possible for the clinician to change threshold limits fordetecting kinematic dysfunctions 824, which can impact the queryaggregated database 840. Additional data may also be collected from thepatient 834 which can then be transmitted to the centralized database838 and presented to the user 836.

FIG. 8 b is a screen shot 850 that illustrates a process of creating acentralized aggregate database via data input, viewing and querying thatcan be used by the user to compare potential clinical outcomes of thesubject. During the process step, the user changes to a list ofprocedures being considered which is depicted as being accomplishable bychecking boxes and drop down menus of procedures being considered ateach spine level. The process step process and mechanism for inputtingadditional data on each subject is depicted as being accomplishable bychecking various boxes and drop down menus listed on the form. Theprocess step present outcomes data to user is depicted as beingaccomplishable via a series of drop down menus and check boxes whichallow the user to specify which outcome measurement is being assessed(pain relief at 2 years, for example), and the output data are presentedin terms of a percentage that had good pain relief. In FIG. 8 c a screenshot 860 for inputting neurological exam results into the aggregateddatabase is shown. FIG. 8 d a screen shot 870 for inputting a patient'spain scores into the Aggregated Database, as well as a process andmechanism to select among various outcomes assessments to be output, areshown.

As an example, the clinical data reporting software system interpretskinematic results of subjects that were tested in a standing (active) orlying down (passive) position, which allows for isolating the muscle orload contribution, generating and/or interfacing with a computer modelof biomechanics specific to a given subject. These computer models ofbiomechanics usually include anatomical and functional models, and byinputting patient specific data along with measurements of howkinematics were different between loaded active and unloaded passivebending, it can be possible to produce explanatory hypotheses that canexplain the observed kinematics based on the anatomical and functionalmodels.

FIG. 9 is a block diagram outlining the process of isolating the causeof any observed dysfunction to either loads or muscles by use of acomputer model of spine biomechanics 942, such as a finite elementanalysis or a model simulating soft tissue dynamics (such as the ANYBODYMODELING SYSTEM™, manufactured by Anybody Technologies, Aalborg,Denmark), combined with kinematic test data collected from subjects in astanding and lying down position 920, which can influence the clinicaltreatment decision of the user by providing data customizable to eachpatient as to how the patients muscles are functioning.

One skilled in the art will appreciate that only one embodiment of thepatient data recording software interface is represented in the abovedescription, and there are many other alternative embodiments ofdifferent joints other than the spine, different mammalian animals otherthan humans, different embodiments and designs other than thosepresented to accomplish the essential function described herein.

B. Surgical Navigation and Patient Positioning

Systems and methods are also contemplated for registering, for example,spinal motion data to an instrument-supported therapeutic procedure,such when using surgical planning, assistance and/or surgical navigationsystems. The systems and methods use the platform disclosed in FIGS. 1-5above in combination with surgical planning, assistance and/ornavigation systems as well as with patient positioning systems.Additionally, the systems and methods can be configured to communicatewith surgical planning, assistance, and/or navigation devices and systemas well as with patient positioning systems. Surgical navigation systemsinclude, for example, robotic surgical instrument systems. Suitablesystems include, for example, a plurality of articulating arms having atleast two articulation joints, where the articulating arms are adaptedto be inserted into an operative space in a substantially straightconfiguration and further adapted to controllably articulate inside theoperative space, with at least three degrees of freedom of movement; atleast one access port adapted to receive the articulating arms; and acontroller adapted to control the articulation of the articulating armsinside the operative space to perform a surgical procedure. See, forexample, U.S. Patent Pub. 2011/0238080 by Ranjit et al. published Sep.29, 2011, entitled Robotic Surgical Instrument System; U.S. Pat. Nos.7,996,110 by Lipow et al. issued Aug. 9, 2011, for Surgical Robot andRobotic Controller; 7,865,269 by Prisco et al. issued Jan. 4, 2011, forRobotic Surgical System and Joint Motion Controller Adapted to ReduceInstrument Tip Vibrations; and 6,228,089 to Wahrburg issued May 8, 2011,for Device for Positioning and Guiding a Surgical Instrument DuringOrthopedic Interventions.

The therapeutic procedure can comprise of instrumentation thatfacilitates a pre-determined therapeutic outcome. For example, spinalmotion and intra-vertebral articulation can be determined by a kinematicmeasuring system. The motion data can then be transferred and registeredto an automated or mechanical device. Suitable instruments include asurgical navigation system, which is automated or manually operated, orcombinations thereof. Surgical navigation systems include, for example,StealthStation® iNAV™ or iOR™ or Treon™ or TRIA™, available fromMedtronic or PiGalileo™ Computer-Assisted Orthopedic Surgery Systemavailable from Plus Orthopedics. Moreover, the therapeutic procedure mayor may not include surgical implants, such as where a therapy istargeted at matching pre-determined outcome to therapy. Inter-vertebralmotion data can also be acquired manually or via an automated system.The system can also be adapted and configured to acquire both static anddynamic parameters. As will be appreciated by those skilled in the art,data to be transferred can be manually or automatically transferred. Anoptimal position and orientation outcome of the spine can also bedetermined by the system and transferred within the system or to anothersystem or user. In at least some embodiments, the such surgicalnavigation system operates such that it can maintain orientation andposition in up to 6 degrees of freedom: moving up and down (heaving);moving left and right (swaying); moving forward and backward (surging);tilting forward and backward (pitching); turning left and right(yawing); and tilting side to side (rolling).

A variety of implants, such as spinal implants, can be used with thesystem, including devices that fuse the spine or facilitate motionpreservation. Such implants can have pre-determined optimalspecifications for position and orientation

FIG. 10 is a simplified block diagram showing system components andinter-connections of an embodiment of the present disclosure thatinvolves the integration of a clinical data reporting software componentwith a surgical navigation system. In such an integral system therewould be three classes of input information. First, data can be recordeddirectly from the patient, which could include such diagnostic data as1020, kinematic data collected from the subject as well as generating acomputer model of spine biomechanics 1042, such as one that has beenprogrammed with patient-specific parameters. Additionally, data couldalso recorded directly from the surgeon or treating physician, such assurgical scenario planning data 1044, surgical alerts generatedpre-operatively, and a list of specific procedures being considered forthe patient 1030. In additional aspects, data can be collected fromsources external to the subject and the physician/surgeon, such asqueries of previously-collected clinical databases 1046 such asnormative data and pre- to post-surgical functional and pain data aswell as data regarding the properties of specific implant devices 1048,such as geometric and functional data. All of these input datasets feeddata into a surgical navigation system 1050, such as those that arecurrently commercially available such as NAVIGATION SYSTEM II (StrykerInstruments, Dallas, Tex.) and STEALTHSTATION S7 (Medtronic Navigation,Louisville, Colo.) or any of the other surgical navigation systemsmentioned previously in this section. Surgical navigation systems canalso include neuro-monitoring systems such as the NVJJB/M5 system(Nuvasive, San Diego, Calif.). Having this input data available for usefor a surgical navigation system is extremely advantageous, because itenables several novel and inventive new capabilities. For example,surgical implant device placement and/or surgical approach could beinformed by patient specific geometric or functional factors that arecurrently not available. Data collected from previous clinical studiescould be applied during surgery through an iterative navigationalprocess accomplished by the surgical navigation system 1050 to optimizedevice placement and surgical approach with a multitude of potentialgoals: (i) to achieve placement and/or function as close to normativevalues as possible; (ii) to achieve a specific type of functionaloutcome; (iii) achieve parameters appropriate to a specific type ofdevice design; (iv) to maximize the chance of reducing pain; and (d) anycombination of the above, plus others.

The surgical navigation system 1050 may also then connect with anoperating table/patient positioner 1052. This operating table/patientpositioner 1052 is then able to communicate data to and from thesurgical navigation system (to: control data to control to position ofthe patient and other data; from: data regarding position of thepatient, and other data), which in turn is in communication with one ormore of the various components (e.g., computer model, kinematic testingresults, specific procedures being considered, surgical scenarioplanning, clinical databases, data regarding specific contemplatedimplants, and/or kinematic testing system). This operating table/patientpositioner 1052 can then be used to put the patient into a specificposture during a surgical operation based on parameters determined viathe surgical navigation system 1050 or any of the components with whichthe surgical navigation system 1050 is in communication. A feedback loopis also contemplated, wherein real time kinematic testing system andother testing modalities to assess position and function of anatomy andinstrumentation can be collected from the patient 1053 and iscommunicated to the surgical navigation system 1050, which can thenutilize this data to adjust either parameters within the surgicalnavigation system 1050, or parameters within the operating table/patientpositioner 1052. Such real time kinematic testing systems 1054 couldinclude imaging modalities, position sensors, motion sensors,electromyography data collection devices, and a host of other datacollection devices. In an alternative embodiment, the operatingtable/patient positioner 1052 can be connected directly to the variouscomponents of the system (e.g., computer model, kinematic testingresults, specific procedures being considered, surgical scenarioplanning, clinical databases, data regarding specific contemplatedimplants, and/or kinematic testing system) without the use of a surgicalnavigation system (for such a configuration, all of the connectionsgoing into the surgical navigation system 1050 would instead connectdirectly to the patient positioner 1052, thus bypassing the surgicalnavigation system 1050).

FIG. 11 shows the center of rotation concept as it applies to lumbarspine levels. Center of Rotation (COR) is a point (x, y) on a plane(sagittal and transverse) that corresponds to the “fulcrum region” of avertebral level (i.e. where forces are concentrated during motion). Thepresent disclosure could use COR measurements for each patient in loadedactive (i.e. muscle-involved) bending and unloaded passive (i.e. nomuscles involved) bending. Coronal and sagittal plane COR measurementscould be taken, transverse plane COR can also be derived from these.Normative measurements (i.e. what is “normal”), based on clinical trialsconducted on asymptomatic subjects are represented graphically. One waythis is valuable to users is to know how COR changes from standing tolying: surgeons operate on patients while they are lying down, howevertheir targets are usually based on normal operating conditions (whichare standing up). Therefore knowing how a given parameter, such as COR,changes from standing to lying can help the surgeon achieve a targetstanding COR based only on the geometry and orientation of the anatomyin the lying posture.

FIG. 12 is a table that describes, according to one embodiment of thepresent disclosure, some ways in which functional targets could bevaluable in a surgical navigation system intended for spine surgery. Forexample, the navigation target could be the location and orientation ofthe superior and inferior endplates of a fusion construct. In this casethe biomechanical goal would be to ensure that adjacent level CORs areas close to “normal” as possible. The clinical benefit would thereforebe to avoid abnormal facet loading (if COR is too anterior), off-loading(if too posterior), and left/right imbalances. In another example, thenavigation target would be the placement of inter-body and motionpreserving devices on vertebral endplate. In this case the biomechanicalgoal would be to ensure device overlaps with COR of the joint, aligningforces through the device and avoiding problematic moment arms. Theclinical benefit would include: (1) to take advantage of Wolf's law tooptimize bone in-growth, and/or (2) to reduce stressing moment arms toavoid failure of construct.

FIG. 13 shows step one of a hypothetical example two step process inwhich functional targeting could be utilized in a spine surgicalnavigation system. In this figure, a sagittal plane routine is describedwherein the desired position and location of endplates is achieved viadevice sizing and placement distraction or compression along posteriorrods. By varying the geometry of the fusion construct, the COR atadjacent levels can be affected such that they are moved into anorientation that is deemed to be more optimal by the surgeon, based onfor example the location that is observed in asymptomatic subjects. Asimilar routine could be done for coronal pane. This demonstrates anexample workflow for a fusion construct; similar workflows could beaccomplished for other spine surgical constructs (motion preserving,interspinous devices, etc) as well as for other joints.

FIG. 14 shows step two of a hypothetical example two step process inwhich functional targeting could be utilized in a spine surgicalnavigation system. According to this figure, Step two of the two stepprocess is to modify the fusion construct as necessary to ensurecoverage by an interbody device of the fulcrum region of the fusedlevel. This is accomplished via several sub-steps: (a) project new“connector lines” between the “new” locations of the COR of the adjacentlevels; (b) Determine the region on superior endplate of the inferiorvertebra of the index level (L5 in this case) endplate where “new” CORconnector lines intersect (marked “x”); (c) this is the “fulcrum region”that needs to be “covered” by the interbody device; (d) Adjust interbodyconstruct to ensure “coverage” of the “fulcrum region”; (e) This isshown for coronal plane; a similar routine is also done for the sagittalplane. Although FIGS. 13 and 14 contemplate this process applied to afusion surgery, one skilled in the art would appreciate that there aremultiple other embodiments which could be directed to: optimize thefusion construct geometry based on different parameters than COR,optimize the fusion construct based on other uses of COR, optimize othertypes of surgical constructs associated with other types of surgeriesfor COR and other parameters.

The inputs, information and reports can be transmitted through either adirect wire-based electronic connection between the two or morecomponents, or through a wireless connection, and can be of the typethat is derived from computer programming or from operator, user orsubject input, or from a combination of computer programmed informationplus operator, user and/or subject input.

C. Imaging System Moveable within a Vertical Plane

The imaging system moveable within a vertical plane is an apparatusproviding input image data for the measurement system that assists withimaging during joint operation. It consists of a medical imaging systemmounted to a free floating, ballasted vertical plane, so that themedical imaging system can be moved in tandem with the motion of thejoint to keep joint anatomy within a field of view (for example keepinga knee in a field of view as a live human testing subject is walking).It can be operated in a manual or automatic mode, as further describedbelow.

FIG. 15 is a block diagram of an imaging system moveable within avertical plane, operating in manual mode. The imaging system imagecollection device 1500 could be an image intensifier, a flat paneldetector, or any number of other medical diagnostic image collectiondevices. The imaging system image collection device 1500 is free to movewithin a vertical plane, via movable connectors to a frame assembly 1512and base that rests upon the floor. Ballast system 1510 and frameassembly base 1512 are connectable via a movable connector, such aslinear bearings, that allow for the motion of the imaging system imagecollection device 1500 motion within a vertical plane. The ballastsystem 1510 can be rigidly connected to the frame assembly and base1512, and movably connected to the imaging system image collectiondevice 1500 such that the weight of the imaging system image collectiondevice 1500 is fully ballasted. With the ballast system 1510 engaged,the only forces required to move the imaging system image collectiondevice 1500 within the vertical plane are those required to overcome thedevices inertia. The target joint anatomy 1502 for a particularprocedure, a knee for example, is then connected to the imaging systemimage collection device 1500, such that the entire joint region ofinterest can remain in the field of view for the imaging of the jointduring operation. The joint can be connected in such a manner as toreduce extraneous movement outside a desired target range of motion.

FIG. 16 is a block diagram of the imaging system moveable within avertical plane, operating in automatic mode. In automatic mode, thedescriptions of the components and the connections between them are nodifferent than for manual mode, for components imaging system imagecollection device 1600, ballast system 1610, and frame assembly and base1612. In manual mode, it is the motion of the joint, as transmitted viaa connection such as a rod, that provides the forces to move the imagingsystem image collection device 1600. However, in automatic mode this isaccomplished via an actuator 1608 that is connected to an automaticcontrol system 1606. The automatic control system or actuator controlsystem 1606 receives signals coming from the position/motion sensor1604, which in turn is connected to a target joint anatomy 1602, suchthat the position/motion sensor 1604 senses the motion of the targetjoint anatomy. The automatic control system 1606 is then able to processthis input data and produce control signals cause an actuation of theactuator 1608 to move the imaging system image collection device 1600.Overall, the motion of the imaging system image collection device 1600should track the motion of the target joint anatomy such that the entirejoint region of interest can remain in the field of view even as thejoint anatomy 1602 moves relative to the frame assembly and base 1612.The actuator 1608 connects to the imaging system image collection device1600 such that it can affect its motion within a vertical plane. Theactuator 1608 is connected or connectable to the actuator control system1606 and the position/motion sensor 1604, via a connection sufficientfor transmitting control signals and position/motion data, such as awired or wireless connection. The actuator control system 1606 is anelectronic control system, such as a programmable logic controller or alaptop computer, that is capable of processing position and motionsignals coming from both the position/motion sensor 1604 as well as fromthe actuator 1608, and of producing actuator control signals to affect amotion as described herein.

The image data can be transmitted through either a direct wire-basedelectronic connection between the two or more components, or through awireless connection, and can be of the type that is derived fromcomputer programming or from operator, user or subject input, or from acombination of computer programmed information plus operator, userand/or subject input. One skilled in the art will appreciate that thereare many shapes, sizes, and configurations of the imaging systemmoveable within a vertical plane required for various mammalian joints.

A collimator device 1713 may be optionally attached to either or both ofthe attachment arms 1701 and/or 1705 for use in the case of ionizingradiation based imaging modalities. This collimator device is intendedto block the path of ionizing radiation for one or both of two purposes:(1) minimize the dose of absorbed radiation on the part of the patient,and (2) minimize “flare”, which can degrade the contrast of medicalimages and can occur when X-rays pass unimpeded from the source to thedetector without first passing through the patient. This collimatordevice is composed of a leaded material or some other material withsufficient density as to partially or completely block ionizingradiation from passing through it. Stationary collimator devices that donot adjust during imaging are not useful, as the field of interestwithin the imaging frame changes as the joint of interest is inoperation during testing. Therefore the collimator device 1713 isintended to maintain a changing field of interest within the imagingframe as the position of the patient's anatomy changes as a function ofnormal joint operation, such that “flare” and radiation dose to thepatient are both minimized while not obscuring any of the physiologicstructures of interest. In one embodiment, the collimator connects toboth attachment arms 1701 and 1705 according to FIGS. 17A-B so that onlyspecific band around each attachment arm is imaged. For situations inwhich it is feasible, it is ideal to place the collimator between thepatient and the radiation source so as to block radiation that wouldhave imaged parts of the patient's anatomy that are not of interest forthe prescribed diagnostic study. The collimator device 1713 may alsoincorporate an actuator that is intended to change the position andgeometry of the shielding pieces dynamically during the tested motion.This actuator can be controlled by an electronic control system thatincorporates stored input data or real time input data, both data comingfrom other parts of the motion control device or from another devicesuch as an imaging device or a posture assistance device. The purpose ofthis functionality of the collimator device is to capable of dynamicallyadjusting the geometry of the shield during tested motion so as tomaximize the benefit of the collimator device in terms of reducingradiation dose to the patient or in terms of reducing “flare”, or both.

The apparatus can further be adapted and configured to keep a specificpart of the patient's anatomy within the imaging field of interestduring imaging. This can be accomplished by an imaging field adjustmentmechanism capable of calculating the positional adjustments necessary tokeep the joint of interest within and/or centered within the imagingfield, then producing a movement between the support frame base 1717 andthe support frame vertical member 1715, such that the specific part ofthe patient's anatomy is held within and/or centered within the field ofimaging. In one embodiment, this imaging field adjustment mechanismwould function as follows: (1) while attached to the apparatus, thepatient is moved to extreme position #1 of the motion sweep that isbeing studied; (2) the apparatus is positioned relative to the medicaldiagnostic device such that the anatomy of interest on the patient iscentered in the field of image of the diagnostic device; (3) thisrelative position between the imaging device and the apparatus isrecorded as extreme position #1; (4) the patient is then moved toextreme position #2 of the motion sweep that is being studied; (5) thisrelative position between the imaging device and the apparatus isrecorded as extreme position #2. Once these two extreme relativepositions between the apparatus and medical diagnostic device have beenrecorded, the imaging field adjustment mechanism then affects a relativemotion between the support frame base 1717 and the support framevertical member 1715 from extreme position #1 to extreme position #2,and possibly back again, in such a way that this relative motion issynchronized with the motion sweep of the apparatus to hold a specificpart of the patient's anatomy within and/or centered within the imagingfield of interest. Furthermore, the calculation of motion between thesupport frame base 1717 and the support frame vertical member 1715required to keep the anatomy of interest within the imaging field can berecorded and integrated into the computation of the range of motion ofthe specific joint of interest. In an alternative embodiment of theimaging field adjustment mechanism, an image centering marker is placedon the patient that denotes where the center of the imaging field shouldbe positioned. The image centering marker interacts with the medicaldiagnostic device in such a way that the center of the imaging fieldalways remains fixed on the image centering marker. So as to notinterfere with the anatomy of interest, the image centering marker doesnot have to be in the actual center of the imaging field, but instead ina position within the image that remains relatively fixed throughout themotion. Data encoding devices can be optionally attached to either ofthe attachment arms 1701 and 1705 and/or the patient and data to betransmitted directly to the medical images or other diagnostic formats.During operation of the device, there are several sets of data that canbe generated by the operation of the motion control device or by theoperation of other devices used during testing, such as the attachmentmechanisms 1703 and 1707, or the medical diagnostic device. Such datacould include: time synchronization data which is data indicating theexact point in time when the motion device begins and ends a testedmotion sequence or a surgical step; the position of each or both of theattachment arms 1701 and 1705, which could be a goniometer measurement,a protractor measurement, or a measurement of the displacement of eachattachment arms 1701 and 1705 relative to the starting position orrelative to the attachment mechanisms 1703 and 1707; parametersassociated with the actuators, such as the level of applied force,displacement, velocity, or other parameters; the weight applied to theattachment arms 1701 and 1705 by the patient at any given moment; theforce applied by the subject on the attachment arms 1701 and 1705 at anygiven moment; the displacement, velocity, or other parameters associatedwith the imaging field adjustment mechanism, or any other measurementparameter that is relevant to the tested motion and that can begenerated by, for example, sensors included within the motion controldevice or by an input from a data source external to the motion controldevice, such as the medical diagnostic device. The data encoding devicemay either be mechanical or digital devices that are capable ofproducing discernable analog or digital markings within the field ofimaging that therefore get captured on the medical images resulting fromthe operation of the present disclosure (when the medical diagnosticdevice is a medical imaging device) that: (1) do not interfere with partof the field of imaging of interest for the prescribed diagnostic study,(2) can transmit data via the image that can be decoded at a later pointin time such that all encoded data can be derived entirely through ananalysis of each medical image. In one embodiment of the presentdisclosure using X-ray based fluoroscopy imaging, the data encodingdevice can be a radio-opaque protractor showing the angular displacementof the attachment arms 1701 and 1705, or alternatively could be aradio-opaque analogue needle-gauge to measure the current through theactuator at any point in time.

Different orientations of the diagnostic imaging system: The presentdisclosure contemplates a mechanism adapted and configured to performdiagnostic imaging of a joint where the field of imaging is fixed inspace; however a diagnostic imaging system that does not have a field ofimaging that is fixed in space could also be utilized. In such a case,the diagnostic imaging equipment would be operably moveable so that thefield of imaging does not stay fixed in space, but instead would stayfixed with respect to: (1) the motion platform, (2) a landmark on thesubject, or (3) any trajectory defined by the operator.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

1-25. (canceled)
 26. A system for evaluating kinematic data from apatient comprising: an imaging system adapted to capture one or moreimages of a target joint from a patient; a modeler adapted to provide amodel of a target biomechanical behavior for the target joint; acomparer adapted to compare the one or more images of the target jointwith the computer implemented model and generate resulting image. 27.The system of claim 26 further comprising a communication network. 28.The system of claim 26 further comprising one or more of a computer, asmart phone, and a tablet.
 29. The system of claim 26 further comprisinga database of kinematic data.
 30. The system of claim 26 furthercomprising a results viewer.
 31. A system for obtaining kinematic datafrom a patient comprising: an imaging system adapted to capture one ormore images of a target joint from a patient; an apparatus for measuringjoint motion comprising a passive motion device adapted and configuredto continuously move a joint of the subject through a range of motion,the passive motion device further comprising, a platform base, and apassive motion platform further comprising a static platform connectedto an upper surface of the platform base, a movable platform connectedto at least one of the static platform or an upper surface of theplatform base, wherein the static platform is adjacent the movableplatform wherein movement of the movable platform is achieved inoperation by a motor in communication with the moveable platform, and animaging device adapted and configured to image the joint of the subjectduring the motion of the passive motion device a comparer adapted tocompare the one or more images of the target joint with the computerimplemented model.
 32. The system of claim 31 further comprising acommunication network.
 33. The system of claim 31 further comprising oneor more of a computer, a smart phone, and a tablet.
 34. The system ofclaim 31 further comprising a database of kinematic data.
 35. The systemof claim 31 further comprising a results viewer.
 36. A surgical systemcomprising: an imaging system adapted to capture one or more images of atarget joint from a patient; an apparatus for measuring joint motioncomprising, a passive motion device adapted and configured tocontinuously move a joint of the subject through a range of motion, thepassive motion device further comprising, a platform base, and a passivemotion platform further comprising a static platform connected to anupper surface of the platform base, a movable platform connected to atleast one of the static platform or an upper surface of the platformbase, wherein the static platform is adjacent the movable platformwherein movement of the movable platform is achieved in operation by amotor in communication with the moveable platform, and an imaging deviceadapted and configured to image the joint of the subject during themotion of the passive motion device; and a device having a plurality ofarticulating arms having at least two articulation joints, thearticulating arms being adapted to be inserted into an operative spaceand further adapted to controllably articulate inside the operativespace, with at least three degrees of freedom of movement, at least oneaccess port adapted to receive the articulating arms, and a controlleradapted to control the articulation of the articulating arms inside theoperative space to perform a surgical procedure.
 37. The system of claim36 further comprising a communication network.
 38. The system of claim36 further comprising one or more of a computer, a smart phone, and atablet.
 39. The system of claim 36 further comprising a database ofkinematic data.
 40. The system of claim 36 further comprising a resultsviewer.
 41. An imaging system comprising: a motion device forcontinuously moving a mammalian joint; an imaging device mounted to afree floating, ballasted vertical plane, wherein the imaging device ismoveable relative to the motion device during use to maintain a targetanatomy within a targeted field of view; and a connector adapted toconnect the imaging device to the motion device such that the imagingdevice and motion device move together when activated.
 42. The system ofclaim 41 further comprising one or more actuators in communication withthe processing system and adapted to reposition the imaging device inresponse to the instruction.
 43. The system of claim 41 furthercomprising one or more of each of: a collimator, one or more motionsensors positionable on a patient and in communication with one or moreof the imaging device and one or more re4cording sensors; and aprocessing system for processing information from the one or more motionsensors to generate an instruction.
 44. The system of claim 43 furthercomprising one or more actuators in communication with the processingsystem and adapted to reposition the imaging device and motion device inresponse to an instruction.
 45. The system of claim 43 wherein theinstruction is at least one of automatically generated,semi-automatically generated, or manually generated.
 46. A method forcomputer-assisted analysis of kinematic data, the method comprising:encoding a kinematic evaluation algorithm as one or more decision trees,each decision tree further comprising one or more decision pointscomprising one or more questions; and one or more termination points,providing one or more images for a patient from an imaging system;initiating an evaluation by identifying one or more proposed proceduresfor the patient; evaluating the proposed procedure applied to the one ormore images from the imaging system according to the algorithm;comparing the evaluation of the proposed procedure to a user profile;and providing a summary of one or more alerts for the one or moreproposed procedures based on the user profile and the one or morepatient images.
 47. A method for computer-assisted analysis of kinematicdata, the method comprising: aggregating kinematic data from two or morepatients into a database; encoding a kinematic evaluation algorithm asone or more decision trees, each decision tree further comprising one ormore decision points comprising one or more questions; and one or moretermination points, providing one or more images for a patient from animaging system according to the algorithm; initiating an evaluation byidentifying one or more proposed procedures for the patient; evaluatingthe proposed procedure applied to the one or more images from theimaging system and the database of aggregated data; comparing theevaluation of the proposed procedure to a user profile; and providing asummary of one or more alerts for the one or more proposed proceduresbased on the user profile and the one or more patient images.